Why China's drug approval backlog spiked last year
- There were 18,500 drugs awaiting approval in China at the end of 2014, according to the Center for Drug Evaluation. That's more than a 30% rise compared to 2013.
- There are also 8,868 clinical trial applications that are under consideration.
- The Chinese pharmaceutical market is considered a hot spot for drug developers, because it it growing rapidly and currently the second largest pharma market in the world.
According to IMS, the Chinese pharma market will be approximately $185 billion by 2018—one reason that it is such a huge draw to drugmakers in China and the rest of the world.
However, operating in this market is not easy. First, there's the approval process, which takes an average of six to eight years. Not only is there the problem of very stringent approval guidelines and arduous laws, but there are also problems related to corruption and the fact that many rural communities and municipalities are still very backwards compared with urban centers. Bribery is also a major challenge.
Despite all of these factors, the market shows no signs of slowing and biopharma companies are continuing to work with Chinese regulatory officials to gain approvals and operate as effectively as possible in the Chinese marketplace.